The goal of the study is to demonstrate Spinal Transforaminal NeuroStimulation effectiveness with FAST and other waveforms / combinations to relief neuropathic peripheral pain in chronic neuropathic pain patients, at low risk and low energy consumption.
Subject has ≥ 18 years and ≤ 80 years
Subject has a global Visual Analogic Scale ≥ 5
Subject has non-cancer pain with a significant neuropathic component for at least 6 months.
Subject has stable pain for at least 30 days
None
Single group
Lead(s) and Implantable Pulse Generator implantation
Device8-contact lead(s) will be radiologically positioned within the spinal foramen under awake anesthesia in order to optimize paresthesia coverage. Awake anesthesia will allow patients to be tested during the surgery in order to determine the sweet spot and the optimal paresthesia coverage using the PREDI-P platform for a single lead. A trial phase will be performed for a period of 7 days in order to assess the benefits of stimulation according to the HAS (French Health Authority) guidelines. Subjects who succeed the lead trial will receive a permanent implant depending on the patient electrical consumption during the lead trial period or according to the implanter decision.
The primary outcome for evaluating pain-related health is the mean absolute change in Multidimensional Clinical Response Index.
The Multidimensional Clinical Response Indexwas previously developed and validated to evaluate the pain-related health state of PSPS-T2 patients. This weighted composite outcome includes pain intensity, functional disability, quality of life, psychological distress and pain mapping surface. The Multidimensional Clinical Response Indexis a score that ranges from 0 (worst pain-related health status) to 10 (best pain-related health status). The score has been used in several studies evaluating efficacy of different neurostimulation modalities.
Absolute change in pain intensity between baseline and 1-, 3- and 6-month post-Spinal Transforaminal NeuroStimulation follow-up.
Will be used : Pain Visual Analogic Scale (VAS). Pain intensity is measured on a 0-10 scale (0 = no pain ; 10 = worst possible pain).
Evaluation of patient satisfaction at 1-, 3- and 6-month post-Spinal Transforaminal NeuroStimulation.
Patient satisfaction will be assessed using patient Global Impression of Change questionnaire (PGIC).
To evaluate the effects of Spinal Transforaminal NeuroStimulation on neuropathic pain symptoms.
Evaluation of intensity of each symptom (numbness, burning sensation, tingling, allodynia, electric shock, hypoesthesia) using the PainDetect questionnaire.
Surface (cm²) of each symptom calculated using the Pain mapping software.
To evaluate the effects of Spinal Transforaminal NeuroStimulation on neuropathic pain symptoms.
Click on the lead sponsor to view all of their trials.
